目的 建立RP-HPLC梯度洗脫法測定阿托伐他汀鈣原料藥中阿托伐他汀鈣。方法 Symmetry shield RP-C18色譜柱（250 mm×4.6 mm，5 μm）；以磷酸鹽緩沖液（pH值2.5）為流動相A，乙腈–甲醇–水（770∶50∶180）為流動相B，進行線性梯度洗脫；檢測波長246 nm；柱溫40 ℃；體積流量1.0 mL/min；進樣體積20 μL。結(jié)果 阿托伐他汀鈣線性范圍為10.655～31.965 μg/mL（r＝0.999 8)，平均回收率為98.2%，RSD值為0.23%（n＝6）。結(jié)論 該方法準確可靠，專屬性強，穩(wěn)定性高，可更好地控制阿托伐他汀鈣原料的質(zhì)量。

Objective To establish a gradient elution method of RP-HPLC to determine atorvastatin calcium in atorvastatin calcium bulks drug. Methods The column was Symmetry shield RP-C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of a KH2PO4 buffer (adjust the pH value to 2.5) (A) and methanol - acetonitrile - water (50∶770∶180) (B). The detection wavelength was 246 nm and the column temperature was 40 ℃. The flow rate was 1.0 mL/min with 20 μL injection volume. Results Atorvastatin calcium had a good linearity in the range of 10.655 — 31.965 μg/mL (r=0.999 8). The average recovery was 98.2% with RSD 0.23% (n= 6). Conclusion The method is accurate, reliable, sensitive, and reproducible, which could be used for the quality control of atorvastatin calcium bulks drug.